Oral Health in Patients With Severe Eating Disorders
ConditionOral Health Related Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKarolinska Institutet
About this trial
The overall aim of the research project is to assess whether the quality of life of patients with severe eating disorders is improved by dental treatment.
Patients diagnosed with anorexia nervosa, bulimia nervosa or non-specific binge eating disorder with extensive dental treatment need will be treated with resin composite restorations or prosthetic therapy. The primary outcome measures is oral health related quality of life. Secondary are orofacial functions and oral esthetics. Patients will be compared to a waiting list.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with anorexia nervosa, bulimia nervosa or non-specific binge eating disorder for a minimum of 10 years = definition of a "severe" eating disorder where extensive dental damage can be anticipated to find.
Need of dental treatment of at least six teeth in one jaw,
Disqualifiers
Age <18 years or patients unable to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Dental rehabilitation with either composite resin of crown therapy
Procedure/SurgeryPatients in group 1 will be treated with minimal invasive treatment, with restorative composite fillings. Patients in group 2 will be treated with prosthetic rehabilitation, dental crowns.
Waiting list
Other interventionWaiting list. Patients randomized to this group will not receive any intervention but answer questionnaires after 4 months on waiting list
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Oral rehabilitationExperimental treatment 1 intervention
Group B: Waiting listOther 1 intervention
Trial outcomes
Primary outcomes
1
Oral health related quality of life OHIP-49
OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.
Time frame
Before treatment2
Oral health related quality of life OHIP-49
OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.
Time frame
4 months3
Oral health related quality of life OHIP-49
OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.
Time frame
12 months4
Oral health related quality of life OHIP-49
OHIP-49 is a survey with 49 questions divided into 7 subgroups: Functional limitation, Physical pain, Psychologic disability, Social disability, Handicap, Orofacial Appearance and Psychosocial Impact. The categories will be graded from 0 to 4 on a Likert Scale (never = 0, seldom= 1, sometimes = 2, fairly often = 3, and very often = 4). The internal reliability, and test/retest reliability and validity of the OHIP-49 has previously been established. Since OHIP-49 measures capture both improvements and declines in oral health status, the instrument enables the possibility to conceptualize and analyze change longitudinally.
Time frame
24 monthsSecondary outcomes
1
Orofacial function (JFL-S)
JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws \[18\]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.
Time frame
Before treatment2
Orofacial function (JFL-S)
JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws \[18\]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.
Time frame
4 months3
Orofacial function (JFL-S)
JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws \[18\]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.
Time frame
12 months4
Orofacial function (JFL-S)
JFLS is an instrument used for evaluating functional limitations. It measures mastication, vertical jaw mobility, verbal and emotional expression as well as miscellaneous functions such as swallow food and yawn. This instrument is a 20-item questionnaire which exhibits good reliability and validity and has been shown to be useful in assessing functional limitations of the jaws \[18\]. Subjects rate their jaw functional limitations on a numeric rating scale (0- 'no limitation', 10- 'extreme limita- tion'). Total score can range from 0 to 200, where 200 is the highest score which indicates extreme limitations.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Public Dental Health Service in Stockholm AB
Collaborator
Source ClinicalTrials.gov